高效液相色谱法测定紫杉醇注射液含量

Determination of the contents in Paclitaxel Injection by HPLC

目的建立测定紫杉醇注射液含量的HPLC外标法。方法采用LunaC18色谱柱,甲醇-水-乙腈(25: 40:35)为流动相,检测波长为227nm,流速1．0 ml·min-1。结果在3mg/ml～60mg/ml范围内,紫杉醇浓度与其峰面积的线性关系良好(r=0．9999),高、中、低3种浓度的平均回收率为99．2％～100．6％,RSD为0．23％～0．61％。结论方法简便、快速、准确,与国家标准中内标法相比含量测定结果相近,故可采用外标法作为本品含量测定方法。

Objective To establish an HPLC method for determination of the contents in Paclitaxel Injection by HPLC.METHODS:The separation was performed on a Luna C18 column with UV detection at 227 nm,and the mobile phase consisted of methyl alcohol-H2O-acetonitrile (25:40:35).The flow rate was 1.0 ml/min.RESULTS:The calibration curve was linear(r=0.9999)within the range of 3～60μg/ml for paclitaxel.The average recovery was 100.2%,RSD was 0.40%.CONCLUSION:This method is simple,quick,accurate and effective for determination of the contents in Paclitaxel Injection.The results is near to internal standard method,The established method is suitable for determination of the contents in Paclitaxel Injection.